MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. HIP KIT; LAVAGE, JET

Model Number N/A

Device Problems Device Emits Odor (1425); Overheating of Device (1437); Improper Device Output (2953)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/01/2018

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during the surgery, saline did not come out from this product although the motor was working.At first, this product was working as normally.But, the operation sound changed to abnormally and saline water did not come out from this product at the middle of the surgery.And it was confirmed that this complaint product had the smell like a burned of motor, and battery pack was came to heat.Therefore, the surgeon used an alternative same product to complete the surgery.There was no delay or injury/adverse event reported as a result of this malfunction.No additional information is available.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.Investigation summary: review of the device history record for 00515048201, lot number 63526743, identified no relevant deviations or anomalies.Product examination could not be performed as no product was returned for this complaint.This complaint cannot be confirmed.The root cause of the reported event could not be specifically determined with the provided information.No device was returned for this complaint.It cannot be determined how or when this issue occurred.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

• Brand Name: HIP KIT
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 7643782
• MDR Text Key: 112564198
• Report Number: 0001526350-2018-00586
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 00515048201
• Device Lot Number: 63526743
• Other Device ID Number: (01) 00889024375192
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1